Biomarkers of Protocol Compliance and Product Adherence

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The purpose of this study is to compare tests of vaginal insertion of applicators(visual inspection of returned applicators (VIRA), inspection of returned applicators under ultraviolet (UV) light, and DNA/protein markers) to determine which, if any, warrant use in a clinical trial of a new vaginal microbicide. The study will also determine whether indicators of semen can be detected on applicators and the degree to which they correlate with reported intercourse, and the correlation between vaginal bacteria detected by a vaginal swab and those detected from the applicator. In addition, the study will determine whether several factors that may be encountered in a clinical trial are likely to affect detection of these markers, including storage for 30 days vs. 7 days, wiping applicators after use, the presence of gel, and inter- and intra-woman variability. The study will also assess safety.

Condition or disease

Intervention/treatment

HIV Prevention

Other: HEC placebo gel applicators

Detailed Description:

Screening tests will be performed to detect exclusion criteria. After confirming the absence of point-of-care exclusion criteria, four applicators (#1 to 4, "sham" applicators) will be handled by the participant, but not inserted into the vagina and the gel will be expelled into a waste container. Four applicators (#5 to 8) will be inserted into the participant's vagina, one at a time, by the investigator, removed, and then the gel will be expelled into a waste container. Two applicators (#9 and 10) will be inserted into the participant's vagina, one at a time, and gel will be expelled into the participant's vagina. Finally, two applicators (#11 and 12) will be inserted into the participant's vagina, one at a time, by the investigator, removed and then the gel expelled into a waste container. Applicators #11 and 12 will then be wiped clean with a paper towel. Thus, each participant will provide a total of 12 applicators, half of which will be processed within one week of her visit and half of which will be processed in approximately one month of her visit. Three readers blinded to the status of the applicators (sham, inserted with or without gel expulsion) will determine, by VIRA and UV light assessment, whether or not the applicators were inserted vaginally. Additional laboratory personnel, who will also be blinded to the status of the applicators, will process the applicators for DNA and protein markers of product adherence and protocol compliance.

Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: VIRA [ Time Frame: 7 days after insertion of vaginal applicators ]

Number of applicators on which Y chromosome-associated genes can be detected and degree of correlation between detection and the number of days since last penile/vaginal intercourse [ Time Frame: 7 days after insertion of vaginal applicators ]

Degree of correlation of vaginal species obtained from vaginal applicators and vaginal species obtained from vaginal swabs [ Time Frame: 7 days after insertion of vaginal applicators ]

Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: VIRA [ Time Frame: 30 days after insertion of vaginal applicators ]

Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: UV Light Inspection [ Time Frame: 7 days after insertion of vaginal applicators ]

Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: UV Light Inspection [ Time Frame: 30 days after insertion of vaginal applicators ]

Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: DNA sequences of vaginal bacteria [ Time Frame: 7 days after insertion of vaginal applicators ]

Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: DNA sequences of vaginal bacteria [ Time Frame: 30 days after insertion of vaginal applicators ]

Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: Immunohistochemical tests for protein markers [ Time Frame: 7 days after insertion of vaginal applicators ]

Sensitivity, specificity, PPV, and NPV of the following indicator of vaginal insertion: Immunohistochemical tests for protein markers [ Time Frame: 30 days after insertion of vaginal applicators ]

Number of applicators on which Y chromosome-associated genes can be detected and degree of correlation between detection and the number of days since last penile/vaginal intercourse [ Time Frame: 30 days after insertion of vaginal applicators ]

Degree of correlation of vaginal species obtained from vaginal applicators and vaginal species obtained from vaginal swabs [ Time Frame: 30 days after insertion of vaginal applicators ]

Secondary Outcome Measures :

Difference in detection of these markers when applicators are processed within one week versus approximately 30 days after the participant's visit [ Time Frame: 30 days after insertion of vaginal applicators ]

Difference in the sensitivity, specificity, NPV and PPV of detection of these markers when applicators are wiped off after removal from the vagina [ Time Frame: 7 days after insertion of vaginal applicators ]

Difference in detection of these markers when gel is present, either from a current applicator insertion and gel expulsion or from previous and current applicator insertion and gel expulsion [ Time Frame: 7 days after insertion of vaginal applicators ]

Difference in the sensitivity, specificity, NPV and PPV of detection of these markers when applicators are wiped off after removal from the vagina [ Time Frame: 30 days after insertion of vaginal applicators ]

Difference in detection of these markers when gel is present, either from a current applicator insertion and gel expulsion or from previous and current applicator insertion and gel expulsion [ Time Frame: 30 days after insertion of vaginal applicators ]

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Ages Eligible for Study:

18 Years to 50 Years (Adult)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Sampling Method:

Non-Probability Sample

Study Population

Healthy, non-pregnant, HIV-uninfected women

Criteria

Inclusion Criteria:

18 to 50 years old

In good health, as evidenced by history

No use of vaginal medications in the past 7 days

At least 3 days from the end of their last menses

Willing and able to comply with study procedures

Exclusion Criteria:

Surgery or biopsy of the vagina or cervix within 30 days

Have a history of a total hysterectomy (removal of the uterus and cervix)

Pregnancy

Positive buccal HIV test

Other conditions that, in the opinion of the investigator, would constitute contraindications to participation in the study or would compromise the ability to comply with study protocols, such as any major chronic illness or a major psychiatric disorder (e.g., schizophrenia)

Current participation in any other drug or device study, or any study which, in the opinion of the investigator, would jeopardize interpretation of results of this study